Laboratory Developed Tests



FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests by licensed clinicians. This brings to mind some very practical questions? How do physicians change the logistics of their practice? How can clinical institutions provide specialized care when their tools are taken away? FDA regulation hammers specialized medical practices by throwing the process into a regulatory mill. A test developed by the doctor would now require production by manufacturer, who is subject to layers and layers of regulatory controls. As a consequence, there is no useful or timely turn around for supplying special in vitro reagents. Can the doctor order, receive and use a special reagent the same day now?

The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA’s device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.

You will learn how reporting regulations, such as FDA’s manufacturing regulations (Quality System Regulation (21 CFR Part 820)), Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806) would apply to LDTs. Once you identified the regulatory obligations, the logistical issues will be discussed and the types of game plans that may be necessary.

Areas to be Covered:

Reasons for FDA regulation
Applicable regulations
Use and availability of LDTs
Identify logistical risks
Steps for implementation
Interactive Q&A Session

Who will Benefit:

Clinical laboratories
Pathology practice groups
Medical institutions (hospitals) using Laboratory Developed Tests
Healthcare maintenance organizations
Medical device and diagnostic manufactures
Risk managers for healthcare practices
Regulatory affairs managers for IVD manufacturers
Cost control consultants for healthcare practices

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance